Methods and systems for knotless suture anchoring

ABSTRACT

Methods and systems are provided for securing tissue to bone. A surgical system can include an outer shaft, an elongate inner shaft, and an implantable suture anchor assembly including first and second anchor bodies. The second, more proximal, anchor body has one or more openings extending through a side wall or through opposed side walls thereof. The inner shaft is configured to be received within the outer shaft and through the first and second anchor bodies such that a distal end of the inner shaft protrudes beyond a distal end of the first anchor body. The inner shaft is configured to be removably coupled to the first anchor body such that the inner shaft is configured to be rotated to cause a proximal portion of the first anchor body to move proximally into a lumen extending through the second anchor body and to occlude the opening in the second anchor body.

FIELD

The present disclosure relates generally to methods and devices forsecuring tissue to bone.

BACKGROUND

Tearing of, or the complete or partial detachment of ligaments, tendonsand/or other soft tissues from their associated bones within the bodyare commonplace injuries, particularly among athletes. Such injuriesgenerally result from excessive stresses being placed on these tissues.By way of example, tissue tearing or detachment may occur as the resultof an accident such as a fall, over-exertion during a work-relatedactivity, or during the course of an athletic event. In the case oftearing or a partial or complete detachment of soft tissue from a bone,surgery is typically required to reattach the soft tissue (or a grafttissue) to the bone.

Numerous devices have been used to secure soft tissue to bone. Examplesof such devices include screws, tacks, staples, suture anchors, andsuture alone. In soft tissue repair or re-attachment proceduresutilizing suture anchors, an anchor-receiving hole is drilled into boneat the desired point of fixation or tissue re-attachment, and a sutureanchor is deployed into the hole using an appropriate installation tool.A suture, coupled to the anchor and passed through or around the softtissue, thus becomes effectively locked to the bone, which secures thesoft tissue to the bone.

During a suture anchoring procedure, it can be challenging to deploy thesuture anchor into the anchor-receiving hole. Further, existing sutureanchors and inserter devices used to insert the anchors into bone mayhave certain disadvantages that complicate their use and/or imposecertain undesirable limits. Also, procedures that require the suture tobe tied into a knot can be time-consuming and cumbersome due to inherentspace constraints, which can complicate a surgery.

Accordingly, there is a need for improved methods and systems forattaching tissue to bone.

SUMMARY

In at least some aspects, a surgical system is provided that in someembodiments includes an outer shaft having a lumen extendingtherethrough, a suture anchor including a first anchor body and a secondanchor body, and an elongate inner shaft. The first anchor body has adistal portion, a proximal portion, and a first lumen extendinglongitudinally therethrough. The second anchor body has a distal endmated to a proximal end of the first anchor body and has a second lumenextending therethrough that is configured to receive the proximalportion of the first anchor, the second anchor body having at least oneopening extending through a side wall of the second anchor body at aposition offset from proximal and distal ends thereof. The elongateinner shaft is configured to be removably received within the lumen ofthe outer shaft and through the first and second anchor bodies such thata distal end of the inner shaft protrudes beyond a distal end of thedistal portion, the inner shaft having a driver shaft portion configuredto be removably coupled to the first anchor body within the first lumensuch that the inner shaft is configured to be rotated to cause theproximal portion of the first anchor body to move proximally into thesecond lumen and to occlude the opening of the second anchor body.

The surgical system can vary in many different ways. For example, theopening can be in the form of first and second openings formed throughopposed side walls of the proximal anchor body. As another example, theouter shaft can have a mating feature extending from a distal endthereof and configured to releasably mate with a corresponding matingfeature formed at the proximal end of the second anchor body. As anotherexample, the proximal portion of the first anchor body can have a threadformed thereon. As a further example, a proximal end of the secondanchor body can be configured to be releasably coupled to the outershaft.

In at least some embodiments, the inner shaft has a proximal handlecoupled thereto. Further, in at least some embodiments, the first lumenof the first anchor body has a locking component configured toreleasably mate with the driver shaft portion of the inner shaft.

In at least some aspects, a suture anchor is provided that in someembodiments includes a distal anchor body and a proximal anchor body.The distal anchor body has a distal portion, a proximal portion, and anouter wall defining a first lumen that extends through the distal anchorbody. The proximal anchor body has a distal end mated to a proximal endof the distal anchor body, the proximal anchor body having an outer walldefining a second lumen that extends through the proximal anchor bodyand at least one opening formed through a side wall of the outer wallthat are offset from the distal end and a proximal end of the proximalanchor body. The second lumen is configured to receive the proximalportion of the distal anchor body therein when a locking force isapplied to the distal anchor body.

The suture anchor can vary in many different ways. For example, theopening can be in the form of first and second openings formed throughopposed side walls of the outer wall of the proximal anchor body. Asanother example, the distal portion of the distal anchor body can bedistally tapered. In at least some embodiments, the distal portion ofthe distal anchor body has a proximal shoulder having the proximalportion of the distal anchor body extending therefrom, an outer diameterof the shoulder being greater than an outer diameter of the proximalportion. The proximal shoulder can abut the distal end of the proximalanchor body when the proximal portion of the distal anchor body isreceived within the proximal anchor body.

In at least some embodiments, the proximal portion of the distal anchorbody has an external thread formed thereon that is configured to matewith a corresponding thread formed in the second lumen of the proximalanchor body.

In at least some embodiments, the locking force is a rotational forcethat causes the distal anchor body to be threaded proximally into theproximal anchor body.

In at least some embodiments, the proximal anchor body has at least onebone engaging feature formed thereon.

In at least some aspects, a method of performing a surgical repair isprovided that in some embodiments includes driving an anchor assemblycomprising a proximal anchor body mated to a proximal end of a distalanchor body of the anchor assembly into a hole in a bone, the proximalanchor body having at least one suture passed through at least oneopening formed through at least one side of the proximal anchor body,the suture being passed through the opening such that terminal endportions of the suture pass alongside a driver shaft removably attachedto the anchor assembly, the suture having a portion thereof that isattached to soft tissue. The method also includes rotating the distalanchor body to cause the distal anchor body to move proximally towardsthe proximal anchor body such that a proximal portion of the distalanchor body is received within the proximal anchor body so as to occludethe opening and thereby cause the suture to be secured between an innerwall of the proximal anchor body and an outer wall of the distal anchorbody.

The method can vary in many different ways. For example, the opening caninclude first and second openings formed through opposed sides of theproximal anchor body. As another example, the method can further includeforming the hole in the bone using a distal end of the driver shaft, thedriver shaft extending through the anchor assembly. As another example,the method can further include tensioning the suture while driving theanchor assembly into the bone. As a further example, the method canfurther include tensioning the suture while rotating the distal anchorbody. In at least some embodiments, rotating the distal anchor body tocause it to move proximally towards the proximal anchor body includesrotating the driver shaft.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will be more fully understood from the followingdetailed description taken in conjunction with the accompanyingdrawings, in which:

FIG. 1A is a perspective view of one embodiment of a surgical system;

FIG. 1B is a perspective view of a suture anchor assembly of thesurgical system of FIG. 1A;

FIG. 2 is a cross-sectional view of the surgical system of FIG. 1A;

FIG. 3 is a perspective view of an inner shaft of the surgical system ofFIG. 1A;

FIG. 4 is another perspective view of the surgical system of FIG. 1A;

FIG. 5 is a perspective view of a distal portion of an outer shaft ofthe surgical system of FIG. 1A;

FIG. 6A is a perspective view of a first anchor body of the surgicalsystem of FIG. 1A;

FIG. 6B is another perspective view of the first anchor body of FIG. 6A;

FIG. 6C is another perspective view of the first anchor body of FIG. 6A;

FIG. 7A is a perspective view of a second anchor body of the surgicalsystem of FIG. 1A;

FIG. 7B is another perspective view of the second anchor body of FIG.7A;

FIG. 7C is another proximal view of the second anchor body of FIG. 7A;

FIG. 8A illustrates the surgical system of FIG. 1A, showing a suturecoupled to the system, and the system delivered to a bone;

FIG. 8B illustrates the surgical system of FIG. 8A, showing a distal endof an inner shaft initiating a hole in the bone;

FIG. 8C illustrates the surgical system of FIG. 8B, showing a distal endof an inner shaft driven distally into the bone;

FIG. 8D illustrates the surgical system of FIG. 8C, showing the innershaft rotated;

FIG. 8E illustrates the surgical system of FIG. 8D, showing the suturesecured;

FIG. 9 is a perspective view of another embodiment of a surgical system;

FIG. 10 is a perspective view of a first anchor body of the surgicalsystem of FIG. 9;

FIG. 11 is a perspective view of a second anchor body of the surgicalsystem of FIG. 9;

FIG. 12 is a cross-sectional view of the surgical system of FIG. 9;

FIG. 13 is a perspective view of an inner shaft of the surgical systemof FIG. 9;

FIG. 14 is a perspective view of another embodiment of a surgicalsystem;

FIG. 15 is a perspective view of a second anchor body of the surgicalsystem of FIG. 14; and

FIG. 16 illustrates the surgical system of FIG. 14, showing a suturecoupled to the system, and the system delivered to a bone.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the systems,devices, and methods specifically described herein and illustrated inthe accompanying drawings are non-limiting exemplary embodiments andthat the scope of the present invention is defined solely by the claims.The features illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Various methods, systems, and devices are provided for securing tissueto bone. In general, the methods, systems, and devices can facilitatesecuring suture to tissue. In some embodiments, a surgical system forattaching tissue to bone includes an outer shaft having a lumenextending therethrough, an inner shaft configured to be removablyreceived within the lumen of the outer shaft, and an implantable sutureanchor assembly. The suture anchor assembly includes a distal firstanchor body and a proximal second anchor body configured such that atleast a portion of the distal first anchor body can move proximally intothe proximal second anchor body. For example, in some embodiments, aproximal portion of the first anchor body can be received within a lumenextending longitudinally through the second anchor body.

The second anchor body has one or more openings extending through a sidewall or through opposed side walls of the second anchor body atpositions offset from proximal and distal ends thereof. In an assembledconfiguration, the second anchor body has a distal end thereof mated toa proximal end of the first anchor body. The second anchor body can beremovably mated to a distal end of the outer shaft. In the assembledconfiguration, the inner shaft extends through the outer shaft and thefirst and second anchor bodies (pre-coupled to one another) so as toprotrude from a distal end of the distal first anchor body. The innershaft, which is also referred to herein as a driver shaft, has a drivershaft portion configured to be removably coupled to the first anchorbody within a lumen extending longitudinally through the first anchorbody. In this way, the inner shaft is configured to be rotated to causea proximal portion of the first anchor body to move proximally into thelumen in the second anchor body and to occlude the openings in thesecond anchor body.

A method for performing a surgical repair to attach or reattach softtissue to bone is also provided. In some embodiments, the methodincludes initiating a hole in bone by inserting a distal end of theinner shaft into a bone, the inner shaft extending through the outershaft and through the suture anchor assembly such that the distal firstanchor body is releasably coupled to a portion of the inner shaft. Themethod also includes passing at least one suture through at least oneopening formed in a side wall (or in opposed side walls) of the proximalsecond anchor body such that terminal end portions of the suture passalongside a driver shaft removably attached to the suture anchorassembly. The suture, which can be in the form of multiple sutures, hasa portion thereof that is attached to soft tissue that is to bereattached to the bone. In some embodiments, the suture can be coupledto the suture anchor assembly before the suture anchor assembly isdelivered to a desired location in bone and the inner shaft coupled tothe suture anchor assembly is used to initiate a bone hole. The methodfurther includes driving the suture anchor assembly into the hole formedin the bone. In particular, a suitable force-applying instrument can beused to drive the inner shaft with the suture anchor assembly loadedthereto deeper in the bone hole, to complete the formation of the bonehole. The suture can be tensioned while the suture anchor assembly isbeing driven into the bone hole.

Once the suture anchor assembly is delivered to a desired depth in thebone hole, the method includes applying locking force to the distalfirst anchor body to cause it to move proximally towards the proximalsecond anchor body such that the proximal portion of the first anchorbody is received within the second anchor body. The locking force can berotational force, and the distal first anchor body can be rotated byrotating the inner shaft, a portion of which is coupled to the firstanchor body. The suture can be tensioned while the first anchor body isbeing rotated. The proximal portion of the first anchor body is receivedwithin the second anchor body so as to occlude the openings to cause thesuture to be secured between an inner wall of the proximal anchor bodyand an outer wall of the distal anchor body. The suture can also besecured between the bone and the side wall of the proximal anchor body.

FIGS. 1A-7C illustrate one embodiment of a surgical system 100 thatincludes an outer shaft 102 having a lumen 104 extending therethrough,an implantable anchor assembly including a suture anchor 106, and anelongate awl shaft or inner shaft 108 configured to be removablyreceived within the lumen 104 of the outer shaft 102. The anchorassembly includes the suture anchor 106 that includes a cannulated firstanchor body 110, which is referred to herein as a distal anchor body,and a cannulated second anchor body 112, which is referred to herein asa proximal anchor body, configured such that at least a portion of thefirst anchor body 110 can be inserted proximally into the second anchorbody 112, as discussed in more detail below. The second anchor body 112is disposed proximally to the first anchor body 110, and it has firstand second openings 115 a, 115 b extending through opposed side wallsthereof. It should be appreciated that, in some embodiments, the secondanchor body 112 can have a single opening extending through a sidethereof.

The first anchor body 110 has proximal and distal ends 110 p, 110 d anda lumen 111 extending longitudinally therethrough. The second anchorbody 112 has proximal and distal ends 112 p, 112 d and a lumen 113extending longitudinally therethrough. The first anchor body 110 can bepre-coupled to the second anchor body 112 before the first anchor body110 is driven into the lumen 113 in the second anchor body 112. Whenpre-coupled as shown in FIGS. 1A and 2, the distal end 112 d of thesecond anchor body 112 contacts the proximal end 110 p of the firstanchor body 110.

The first anchor body 110 can have various configurations. In theillustrated embodiment, as shown in FIGS. 1A, 1B, and 6A-6C, the firstanchor body 110 having the lumen 111 extending therethrough has a distalportion 114 and a proximal portion 116 extending from the distal portion114. The distal portion 114 is configured to form a bone hole initiatedby the distal tip of the inner shaft 108. In this example, the distalportion 114 is generally shaped as a truncated cone, and it can havedistal features extending from its distal end. In some embodiments,however, the distal portion 114 can have one or more flat faces, or itcan be configured it any other way. As shown in FIG. 6A, the distalportion 114 is distally tapered and has a proximal shoulder 120 havingthe proximal portion 116 extending therefrom. As shown, the distalportion 114 can have a distal-most portion 114 d terminating at thedistal end 110 d of the first anchor body that is more tapered than amore proximal portion of the distal portion 114. The distal portion 114is configured as a dilator feature that can widen a hole in bone oncethe hole is initiated, such as with a distal end of the elongate shaft108.

In the example illustrated, an outer diameter of the proximal shoulder120 is greater than an outer diameter of the proximal portion 116, andthe proximal portion 116 is formed such that its outer wall at a distalend 116 d thereof is offset from an outer edge of the proximal shoulder120. It should be appreciated, however, that the first anchor body 110can have other suitable configurations. For example, the first anchorbody 110 may not have a shoulder similar to the proximal shoulder 120.Also, a diameter of the proximal-most portion of the distal portion ofthe first anchor body can be the same as that of the proximal portion ofthe first anchor body.

The proximal portion 116 has an external thread 118 formed on an outerwall thereof. In this way, the proximal portion 116 of the first anchorbody 110 can be in the form of a male threaded boss configured to bereceived by a complimentary-shaped female feature formed in the secondanchor body 112. In particular, as in the illustrated embodiment, theexternal thread 118 formed on the proximal portion 116 of the firstanchor body 110 is configured to mate with a corresponding thread formedin the lumen 113 of the second anchor body 112. Thus, as shown in FIGS.2 and 7A-7C, the lumen 113 in the second anchor body 112 has a thread122 formed therein such that the proximal portion 116 of the firstanchor body 110 can be threaded proximally into the lumen 113 in thesecond anchor body 112.

The second anchor body 112 can also have various configurations. In theillustrated embodiment, as shown in FIGS. 1A, 1B, and 7A-7C, the secondanchor body 112 having the lumen 113 extending therethrough is generallycylindrical and has one or more bone engaging features, e.g., ribs 124,formed on its outer wall. However, the second anchor body 112 can haveother bone engaging features formed thereon, such as threads.

In the illustrated embodiment, the second anchor body 112 has the firstand second openings 115 a, 115 b extending through opposed side wallsthereof at positions offset from the proximal and distal ends 112 p, 112d thereof. As shown in FIG. 7A, the openings 115 a, 115 b are formedthrough the side walls of the second anchor body 112 such that theydefine, together with the lumen 113, a tunnel or passageway 115extending laterally across the second anchor body 112. As shown in FIG.7A, each of the openings 115 a, 115 b is formed such that its distal endis offset from the distal end 112 d of the second anchor body 112 at afirst distance d1 that is smaller than a second distance d2 between theproximal end 112 p of the second anchor body 112 and a proximal end ofeach of the openings 115 a, 115 b. It should be appreciated, however,that the openings 115 a, 115 b can be offset at any suitable distances(e.g., substantially the same) from the opposed ends of the secondanchor body, including at different distances among the openings. Also,although two openings are shown, one or more than two openings can beformed in some embodiments. For example, in at least one embodiment, oneopening can be is formed through a side wall of the second anchor body112. The single opening can be formed similar to one of the first andsecond openings 115 a, 115 b.

The openings 115 a, 115 b can be used to pass at least one suturethrough the second anchor body 112, as discussed in more detail below.Further, in use, when the proximal portion 116 of the first anchor body110 is inserted into the lumen 113 of the second anchor body 112, theopenings 115 a, 115 b are blocked or occluded, as shown in FIG. 1B. Thiscauses the suture to be pinched between the inner wall of the secondanchor body 112 and the outer wall of the first anchor body 110.

In an assembled configuration of the surgical system 100, before thesystem 100 is inserted into bone, as shown in FIGS. 1A, 1B, 2, and 4,the elongate inner shaft 108 is received within the lumen 104 of theouter shaft 102 and through the first and second anchor bodies 110, 112such that a distal end 108 d of the inner shaft protrudes beyond thedistal end 110 d of the first anchor body 110. The inner shaft 108 isconfigured to initiate a hole in a bone, and the hole can be dilatedwith the distal portion 114 of the first anchor body 110, as discussedin more detail below.

In some embodiments, the inner shaft 108 and the lumen 111 of the firstanchor body 110 can be configured such that the shaft 108 can bereleasably locked within the lumen 111. For example, a distal portion ofthe inner shaft 108 can fit within a key-hole type feature formed in thelumen 111 that can be configured to releasably lock the distal portionof the inner shaft 108 therewithin. Any suitable lock/key-typeconfiguration of the lumen 111 and the inner shaft 108 can beimplemented.

In the illustrated embodiment, as shown in shown in FIG. 3, the innershaft 108 has a distal driver shaft portion 126, an intermediate portion128, and a proximal portion 130. The intermediate portion 128 can extendthrough the second anchor body 112. The driver shaft portion 126terminates at the distally tapered distal end 108 d and is configured tobe removably coupled to the first anchor body 110. The driver shaftportion 126 can have mating features configured to mate withcorresponding mating features of the lumen 111 of the first anchor body110. For example, the driver shaft portion 126 can have protrusions orblade features 133 (two, in this example, though any number can beformed) extending proximally from a distally tapered end portion (shownas a portion 126 a in FIG. 3) terminating at the distal end 108 d. Amore proximal part 127 of the distal portion 126 having, in thisexample, a smaller outer diameter than the blade features 133, can beconfigured to engage the proximal end 110 p of the first anchor body110.

The blade features 133 can be configured to engage the lumen 111 in thefirst anchor body 110. For example, the lumen 111 can have a lockingcomponent configured to reversibly engage the blade features 133 of theinner shaft 108. FIGS. 6B and 6C illustrate that the lumen 111 haskey-hole features 138 a, 138 b formed on opposed sides from a centralpart of the lumen 111. The lumen 111 in the first anchor body 110 can beconfigured such that its more distal part is larger than the moreproximal portion of the lumen 111 adjacent to the proximal end 110 p.This more distal part of the lumen 111 can be configured as a lockingcomponent that can lockingly receive therein the distal portion 126 ofthe inner shaft 108. For example, when the inner shaft 108 in insertedinto the lumen 111 (e.g., pushed distally while a force is applied), theblade features 333 enter the lumen 111 through the key-hole features 138a, 138 b, which extend distally into the lumen 111 towards the innerlocking component configured to engage the blade features 133. The bladefeatures 133 engage the locking component and, once the inner shaft 108is rotated, the inner shaft 108 becomes locked within the lumen 111. Inthe locked position, the inner shaft 108 prevents the first anchor body110 from axial movement, and in this position the inner shaft 108 can berotated to cause the first anchor body 110 coupled thereto to be alsorotated. To unlock the inner shaft 108, the inner shaft 108 can berotated (e.g., by 90 degrees) and it can be removed from the firstanchor body 110.

Thus, the inner shaft 108 can be inserted into the lumen 111 and theinner shaft 108 can be rotated to be locked within the lumen 111, tothus prevent axial movement of the first anchor body 110 with respect tothe inner shaft 108. In such a position of the inner shaft 108, theinner shaft 108 can be used to drive the suture anchor 106 into the boneand to be rotated to cause the first anchor body 110 to be driven intothe second anchor body 112. The inner shaft 108 in the first, lockedposition can be rotated (e.g., by 90 degrees) so as to be disengagedfrom the distal part of the lumen 111 such that the inner shaft 108 canbe separated from the first anchor body 110.

The first anchor body 110 can be coupled to the driver shaft portion 126of the inner shaft 108 in various ways. For example, the driver shaftportion 126 can be held within the lumen 111 via a friction fit or usinganother engagement approach. As shown in FIG. 2, the proximal end 110 pof the first anchor body 110 can have one or more mating features, suchas, e.g., a circular protrusion 132 configured to engage feature at aproximal end of the driver shaft portion 126. Additionally oralternatively, the first anchor body 110 can have female feature(s)configured to mate with complementary male feature(s) formed on aportion (e.g., the driver shaft portion 126) of the inner shaft 108.

As shown in FIGS. 1A and 1B, the first anchor body 110, coupled to theinner shaft 108, is pre-coupled to the second anchor body 112. In thisway, when a locking force, such as a rotational force, is applied to theinner shaft 108, the first anchor body 110 coupled to the inner shaft108 is caused to be threaded into the lumen 113 in the second anchorbody 112. It should be appreciated, however, that the first anchor body110 can be releasably coupled to the inner shaft 108 (e.g., to thedriver shaft portion 126) in any suitable way.

As also shown in FIG. 2, the intermediate portion 128 of the inner shaft108 extends through the lumen 113 in the second anchor body 112 withoutengaging the lumen 113, such that the inner shaft 108 can move withinthe second anchor body 112. The intermediate portion 128 extends betweenthe distal portion 126 and the proximal portion 130 such that theintermediate portion 128 terminates at a distal shoulder 131 of theproximal portion 130. In the assembled configuration of the system 100,as shown in FIG. 1A, the intermediate portion 128 of the inner shaft 108can be visible through the openings 115 a, 115 b formed through thesecond anchor body 112.

In the assembled configuration of the system 100, as shown in FIG. 2,the second anchor body 112 is disposed such that its proximal end 112 pabuts the shoulder 131. As shown in FIG. 2, the outer shaft 102 havingthe inner shaft 108 extending therethrough is disposed such that theproximal end 112 p of the second anchor body 112 abuts a distal end 102d of the outer shaft 102. In some embodiments, the outer shaft 102 has amating feature extending from the distal end 102 d thereof that isconfigured to releasably mate with a corresponding (e.g., complementary)mating feature formed at the proximal end 112 p of the second anchorbody 112. For example, as shown in FIG. 5, the distal end 102 d of theouter shaft 102 can have protrusions 134 a, 134 b formed on opposedsides of the lumen 104. The protrusions 134 a, 134 b can be configuredto releasably mate complementary recesses or openings 136 a, 136 bformed at the proximal end 112 p of the second anchor body 112, as shownin FIGS. 7A and 7C. It should be appreciated, however, that the outershaft 102 can have one or more mating features of any suitableconfiguration that are configured to releasably mate with correspondingmating feature(s) formed at the second anchor body 112.

FIGS. 8A-8E illustrate one embodiment a method of performing a surgicalrepair. The method is described, by way of example, as performed usingthe system 100 shown in FIGS. 1A-7C, though it should be appreciatedthat the surgical repair method can be performed using other surgicalsystems, including surgical systems in which one or more components aredifferent from those included in the surgical system 100.

FIG. 8A illustrates bone 200 and soft tissue 202 (e.g., a tendon) thatis to be attached to the bone 200 using the surgical system 100, whichis shown in the assembled configuration. In particular, as shown, theinner shaft 108 extends through the outer shaft 102 and through animplantable anchor assembly including the first anchor body 110 (towhich the inner shaft 108 is coupled) and the second anchor body 112such that the inner shaft's distal end 108 d protrudes from the firstanchor body 110. The proximal end of the first anchor body 110 is matedto the distal end of the second anchor body 112 that is coupled to thedistal end of the outer shaft 102.

As shown in FIGS. 8A and 8B, a suture 204 is coupled to the tissue 202,such as by being passed through and/or wrapped around tissue 202. Asshown in FIG. 8A, terminal end portions 204 a, 204 b of the suture 204are passed through the second anchor body 112, as schematically shown byarrows 205, such that the terminal end portions 206 a, 206 b extendthrough the openings 115 a, 115 b extending through the opposed sides ofthe second anchor body 112 and communicating with the lumen 113 in thesecond anchor body 112. In particular, the suture 204 is passed acrossthe second anchor body 112 by being passed through one of the openings115 a, 115 b in the second anchor body 112, across the lumen 113, andthrough another one of the openings 115 a, 115 b. The terminal endportions 204 a, 204 b enter the lumen 113 from one side of the secondanchor body 112 and exit the lumen 113 from the opposed side of thesecond anchor body 112, and the terminal end portions 204 a, 204 bextend at opposed sides of the inner shaft 108. It should be appreciatedthat the single suture 204 is shown by way of example only, as multiplesutures can be used to couple the tissue 202 to the bone 200. Theterminal end portions 206 a, 206 b can be passed alongside a portion ofthe inner shaft 108. The relatively large size of the openings 115 a,115 b enables the use of multiple sutures to attach soft tissue to bone.

Additionally, in some embodiments, the terminal end portions 204 a, 204b of the suture 204 can be passed through only one of the first andsecond openings 115 a, 115 b. The terminal end portions 204 a, 204 bpass through that one opening and extend through the lumen 104 of theouter shaft 102. The terminal end portions 204 a, 204 b can thus extendfrom a proximal end of the lumen 104.

Furthermore, in other embodiments as mentioned above, a single openingcan be formed through a side wall of the second anchor body 112. In suchembodiments, the terminal end portions 204 a, 204 b pass through thesingle opening and extend through the lumen 104 of the outer shaft 102.For example, the terminal end portions 204 a, 204 b can extend from aproximal end of the lumen 104.

Also, although two openings are shown, one or more than two openings canbe formed in some embodiments. For example, in at least one embodiment,one opening can be is formed through a side wall of the second anchorbody 112. The single opening can be formed similar to one of the firstand second openings 115 a, 115 b.

FIG. 8B shows the system 100 loaded with the suture 204 delivered to adesired location in the bone 200 and shows the tip or distal end 108 dof the inner shaft 108 is used to initiate a hole in the bone 200. Asshown, the distal end 108 d is driven into the bone 200 at an initialdepth at the desired location. This initiates a hole in the bone 200.While tension is maintained on the terminal end portions 204 a, 204 b ofthe suture 204 (as shown schematically by arrows 211), the inner shaft108 with the anchor assembly is driven into the bone 200, as shown inFIG. 8C. FIG. 8C shows that a suitable instrument 210, such as mallet,hammer, or other instrument, is used to insert the self-punching shaft108 into the bone 200. The instrument 210 can be used to impact (asshown schematically by an arrow 213) the proximal end of the inner shaft108 to drive the inner shaft 108 into bone 200. In this way, a portionof the inner shaft 108 extending through the first and second anchorbodies 110, 112 is inserted deeper into the desired location in bone200. The distal portion 114 of the first anchor body 110 dilates thehole initiated by the inner shaft's distal end 108 d. As the inner shaft108 is driven distally, the bone hole 212 is formed and the first andsecond anchor bodies 110, 112 are positioned with the hole 212 such thatthey sit distal to or below the surface of the bone 200, as shown inFIG. 8C. In some embodiments, however, a portion of the second anchorbody 112 can sit above the surface of the bone 200. The inner shaft 108can be inserted into the bone 200 at a depth that is sufficient to holdthe suture anchor 106 at a desired position relative to the bone 200.

As shown in FIG. 8C, the tissue 202 coupled to the suture 204 ispositioned at a desired location adjacent to the bone hole 212. Whentension is maintained on the terminal end portions 204 a, 204 b of thesuture 204, the tissue 202 can be brought closer to the bone hole 212 toposition it relative to the bone 200 as desired.

Once the inner shaft 108 with the suture anchor assembly is insertedinto the bone 200 so as to form the bone hole 212 in the desiredlocation, the first anchor body 110 is rotated to cause it to moveproximally towards the proximal second anchor body 112 such that theproximal portion 116 of the first anchor body 110 is received within thesecond anchor body 112 so as to occlude the openings 115 a, 115 b. Thiscauses the suture 104 to be secured between the bone and the side wallof the second anchor body 112 and between inner walls of the secondanchor body 112 component and an outer wall of the first anchor body110.

Locking force can be applied to the first anchor body 110 to cause itsproximal portion 116 to engage with the second anchor body 112. FIG. 8Dillustrates that a proximal handle 160 coupled proximally to the innershaft 108 can be rotated (as shown schematically by an arrows 215), tocause the shaft 108 to rotate and to thereby cause the proximal portion116 of the first anchor body 110 to move proximally into the lumen 113in the second anchor body 112. As a result, the proximal shoulder 120 ofthe first anchor body 110 abuts the distal end 112 d of the secondanchor body 112. The outer shaft 102 can be used to apply force to thesuture anchor assembly 106 while the inner shaft 108 is rotated. FIG. 8Dalso shows that the outer shaft 102 can have a proximal handle 170coupled proximally thereto. The proximal handle 160 of the inner shaft108 is disposed proximally to the proximal handle 170 of the outer shaft102, and the proximal handle 160 is configured to be rotatedindependently of movements of the outer shaft 102. It should beappreciated that the proximal handles 160, 170 are shown by way ofexample only, as handles having any suitable configurations, or anyother suitable mechanisms, can be coupled to the inner and outer shafts108, 102. As the inner shaft 108 and the proximal portion 116 of thefirst anchor body 110 coupled thereto are rotated, the outer shaft 102remains stationary. Tension is maintained on the terminal end portions204 a, 204 b of the suture 204.

During insertion of the suture anchor 106 into the bone hole 212, thebone-engaging features 124 facilitate the engagement of the sutureanchor 106 with the wall of the bone hole 212. The suture 204 becomespinched between the proximal end of the proximal portion 116 of thefirst anchor body 110, and the edges of the side openings 115 a, 115 bin the second anchor body 112, and between the proximal end of theproximal portion 116 of the first anchor body 110 and the undersurfaceof the proximal end of the second anchor body 112.

Once the suture anchor 106 has been inserted into the hole 212 asdesired, the inner shaft 108 can be separated from the first anchor body110, and the outer shaft 102 can be separated from the second anchorbody 112. The inner shaft 108 and the outer shaft 102 can be separatecomponents that can be removed separately. For example, the inner shaft108 can be removed first. Alternatively, in some embodiments, the innershaft 108 and the outer shaft 102 can be coupled in some manner, whilestill allowing for independent rotation of the inner shaft 108. FIG. 8Eillustrates the suture anchor 106 inserted into the bone, with the innershaft 108 and the outer shaft 102 removed. FIG. 8E also schematicallyshows that the terminal end portions of the suture 204 can be trimmed,if desired, such as by using scissors 207. The tissue 202 is thusattached to the bone 200.

The surgical system in accordance with the described embodiments canvary in many suitable ways. For example, the first and second anchorbodies of a suture anchor can have various configurations. Also, aportion of the inner shaft configured to reliably mate with the first,distal anchor body can have various configurations. Other components ofthe surgical system can vary in different ways as well.

FIGS. 9-13 illustrate another embodiment of a surgical system 300 whichoperates similarly to the system 100 of FIGS. 1A-8E. Also, the system300 has similar components to those included in the system 100, and thedescription of such components is therefore not replicated in connectionwith FIGS. 9-13.

FIGS. 9 and 12 show that the surgical system 300 includes an outer shaft302 having a lumen extending therethrough, an implantable anchorassembly having a suture anchor 306, and an elongate awl shaft or innershaft 308 configured to be removably received within the lumen of theouter shaft 302. The assembly's suture anchor 306 includes a firstanchor body 310 and a second anchor body 312 configured such that atleast a portion of the first anchor body 310 can be inserted proximallyinto the second anchor body 312, as discussed in more detail below. Thesecond anchor body 312 is disposed proximally to the first anchor body310 and has first and second openings 315 a, 315 b extending throughopposed side walls thereof.

In this embodiment, the first anchor body 310 has a distal portion 314and a proximal portion 316 having an external thread 318 formed thereonthat is configured to mate with a corresponding thread formed in thelumen of the second anchor body 312. As shown in FIGS. 10 and 12, thedistal portion 314 is distally tapered and its proximal end from whichthe proximal portion 316 extends has an outer diameter that isapproximately the same as an outer diameter of the proximal portion 316.In this embodiment, a lumen extending through the first anchor body 310does not have a lock/key-type inner feature, and the inner shaft 108 canfrictionally or otherwise engage the lumen of the first anchor body 310.

The second anchor body 312 has bone-engaging features, such as ribs 324,formed thereon. The openings 315 a, 315 b extend through opposed sidewalls of the second anchor body 312 at positions offset from theproximal and distal ends 312 p, 312 d thereof. In this example, as shownin FIG. 11, each of the openings 315 a, 315 b is formed such that itsdistal end is offset from the distal end 312 d of the second anchor body312 at a first distance d1′ that is greater than a second distance d2′between the proximal end 312 p of the second anchor body 312 and aproximal end of the opening. When the proximal portion 316 of the firstanchor body 310 is inserted into the lumen of the second anchor body312, the openings 315 a, 315 b are occluded so as to pinch a suturebetween the inner wall of the second anchor body 312 and the outer wallof the first anchor body 310.

As shown in FIG. 13, the inner shaft 108 has a distal driver shaftportion 326 terminating at the shaft's distal end 108 d, an intermediateportion 328, and a proximal portion 330. The driver shaft portion 326,which is configured to be removably coupled to the first anchor body310, has a distal portion 327 a and a proximal portion 327 b. Theproximal portion 327 b has longitudinal protrusions 329 formed thereon,as shown in FIG. 13 (or other suitable surface features can be formed)that are configured to be removably coupled to the first anchor body 310within the inner lumen of the first anchor body 310. The distal portion327 a of the driver shaft portion 326 has a smaller outer diameter thanthe proximal portion 327 b and has a substantially circularcross-section. In the assembled configuration, the distal portion 327 aof the driver shaft portion 326 extends through the distal portion 314of the first anchor body 310. The driver shaft portion 326 of the innershaft 108 can be frictionally or otherwise engaged with the lumen of thefirst anchor body 310. The system 300 can be used to attach soft tissueto bone similar to the way in which the system 100 can be used, asdiscussed above in connection with FIGS. 8A-8E.

In some embodiments, as mentioned above, one opening can be is formedthrough a side wall of a second anchor body of the suture anchor. Thesingle opening can be formed similar to one of the first and secondopenings 115 a, 115 b. FIG. 14 illustrates an example of a surgicalsystem 400 that can be similar to surgical system 100 of FIGS. 1A-8E,and the description of components of the system 400 is therefore notreplicated herein. As shown in FIG. 14, the surgical system 400 includesan outer shaft 402, an implantable anchor assembly including a sutureanchor 106, and an elongate awl shaft or inner shaft 408 configured tobe removably received within a lumen 104 of the outer shaft 402. Similarto suture anchor 106 of system 100 (FIG. 1A), the suture anchor 406includes a first anchor body 410 and a second anchor body 412 configuredsuch that at least a portion of the first anchor body 410 can beinserted proximally into the second anchor body 412. The second anchorbody 412 is disposed proximally to the first anchor body 410, and thesecond anchor body 412 has an opening 717 extending through a side wallthereof. FIG. 15 illustrates the second anchor body 412 having theopening 117.

The system 400 can be used in a method for performing a surgical repair,to (re) attach tissue to bone similar to the manner in which thesurgical system 100 can be used, as discussed above in connection withFIGS. 8A-8E. However, because the single opening 417 is formed in thesecond anchor body 412, a suture can extend through the opening suchthat terminal end portions thereof extend proximally through a lumen ofthe outer shaft 402. Thus, FIG. 16 illustrates bone 500 and soft tissue502 (e.g., a tendon) that is to be attached to the bone 500 using thesurgical system 400. As shown, a suture 504 is coupled to the tissue502, such as by being passed through and/or wrapped around tissue 502.As shown in FIG. 16, terminal end portions 504 a, 504 b of the suture504 are passed through the second anchor body 412 such that the terminalend portions 406 a, 406 b extend through the opening 417 extendingthrough a side wall of the second anchor body 412 and communicating witha lumen in the second anchor body 112. The terminal end portions 504 a,504 b of the suture 504 can be passed through the opening 417, through alumen of the outer shaft 402 (e.g., a lumen that is similar to lumen 104of the outer shaft 102 in FIG. 1A), and the terminal end portions 504 a,504 b of the suture 504 can extend from a proximal end 402 of the outershaft 402, schematically shown in FIG. 16. In use, the suture 504 can betensioned similar to suture 204 of FIGS. 8A-8H. Other steps of themethod for performing a surgical repair using the system 400 can beperformed similar to the manner in which the surgical system 100 can beused, as discussed above in connection with FIGS. 8A-8E.

The described systems and methods provide certain advantages. Forexample, among the advantages is the ease with which the repairtechnique can be performed to securely attach soft tissue to bonewithout the need to tie knots. The described techniques allow tensioningsutures separately from the insertion of a suture anchor into bone.Another advantage is that the anchor is inserted into the bone using anawl shaft (e.g., inner shaft 108 or 308), and no additional instrumentis required to initiate a bone hole.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device, e.g., the shafts, can be selectively replaced or removed inany combination. Upon cleaning and/or replacement of particular parts,the device can be reassembled for subsequent use either at areconditioning facility, or by a surgical team immediately prior to asurgical procedure. Those skilled in the art will appreciate thatreconditioning of a device can utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. Use of suchtechniques, and the resulting reconditioned device, are all within thescope of the present application.

Preferably, the components of the system described herein will beprocessed before surgery. First, a new or used instrument is obtainedand if necessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility.

It is preferred the components are sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).

One skilled in the art will appreciate further features and advantagesof the described subject matter based on the above-describedembodiments. Accordingly, the present disclosure is not to be limited bywhat has been particularly shown and described, except as indicated bythe appended claims. All publications and references cited herein areexpressly incorporated herein by reference in their entirety.

What is claimed is:
 1. A surgical system, comprising: an outer shafthaving a lumen extending therethrough; a suture anchor comprising afirst anchor body having a distal portion, a proximal portion, and afirst lumen extending longitudinally therethrough, and a second anchorbody having a distal end mated to a proximal end of the first anchorbody and having a second lumen extending therethrough that is configuredto receive the proximal portion of the first anchor, the second anchorbody having at least one opening extending through a side wall of thesecond anchor body at a position offset from proximal and distal endsthereof; and an elongate inner shaft configured to be removably receivedwithin the lumen of the outer shaft and through the first and secondanchor bodies such that a distal end of the inner shaft protrudes beyonda distal end of the distal portion, the inner shaft having a drivershaft portion configured to be removably coupled to the first anchorbody within the first lumen such that the inner shaft is configured tobe rotated to cause the proximal portion of the first anchor body tomove proximally into the second lumen and to occlude the opening of thesecond anchor body.
 2. The surgical system of claim 1, wherein the outershaft has a mating feature extending from a distal end thereof andconfigured to releasably mate with a corresponding mating feature formedat the proximal end of the second anchor body.
 3. The surgical system ofclaim 1, wherein the proximal portion of the first anchor body has athread formed thereon.
 4. The surgical system of claim 1, wherein aproximal end of the second anchor body is configured to be releasablycoupled to the outer shaft.
 5. The surgical system of claim 1, whereinthe inner shaft has a proximal handle coupled thereto.
 6. The surgicalsystem of claim 1, wherein the first lumen of the first anchor body hasa locking component configured to releasably mate with the driver shaftportion of the inner shaft.
 7. The surgical system of claim 1, whereinthe opening comprises first and second openings formed through opposedside walls of the second anchor body.
 8. A suture anchor, comprising: adistal anchor body having a distal portion, a proximal portion, and anouter wall defining a first lumen that extends through the distal anchorbody; and a proximal anchor body having a distal end mated to a proximalend of the distal anchor body, the proximal anchor body having an outerwall defining a second lumen that extends through the proximal anchorbody and at least one opening formed through a side of the outer wallthat is offset from the distal end and a proximal end of the proximalanchor body, the second lumen being configured to receive the proximalportion of the distal anchor body therein when a locking force isapplied to the distal anchor body.
 9. The suture anchor of claim 8,wherein the opening comprises first and second openings formed throughopposed sides of the outer wall of the proximal anchor body.
 10. Thesuture anchor of claim 8, wherein the distal portion of the distalanchor body has a proximal shoulder having the proximal portion of thedistal anchor body extending therefrom, an outer diameter of theshoulder being greater than an outer diameter of the proximal portion.11. The suture anchor of claim 10, wherein the proximal shoulder abutsthe distal end of the proximal anchor body when the proximal portion ofthe distal anchor body is received within the proximal anchor body. 12.The suture anchor of claim 8, wherein the proximal portion of the distalanchor body has an external thread formed thereon that is configured tomate with a corresponding thread formed in the second lumen of theproximal anchor body.
 13. The suture anchor of claim 8, wherein thelocking force is a rotational force that causes the distal anchor bodyto be threaded proximally into the proximal anchor body.
 14. The sutureanchor of claim 8, wherein the proximal anchor body has at least onebone engaging feature formed thereon.
 15. A method of performing asurgical repair, comprising: driving an anchor assembly comprising aproximal anchor body mated to a proximal end of a distal anchor body ofthe anchor assembly into a hole in a bone, the proximal anchor bodyhaving at least one suture passed through at least one opening formedthrough at least one side wall of the proximal anchor body, the suturebeing passed through the opening such that terminal end portions of thesuture pass alongside a driver shaft removably attached to the anchorassembly, the suture having a portion thereof that is attached to softtissue; and rotating the distal anchor body to cause the distal anchorbody to move proximally towards the proximal anchor body such that aproximal portion of the distal anchor body is received within theproximal anchor body so as to occlude the opening and thereby cause thesuture to be secured between an inner wall of the proximal anchor bodyand an outer wall of the distal anchor body.
 16. The method of claim 15,wherein the opening comprises first and second openings formed throughopposed side walls of the proximal anchor body
 17. The method of claim15, further comprising forming the hole in the bone using a distal endof the driver shaft, the driver shaft extending through the anchorassembly.
 18. The method of claim 15, further comprising tensioning thesuture while driving the anchor assembly into the hole.
 19. The methodof claim 15, further comprising tensioning the suture while rotating thedistal anchor body.
 20. The method of claim 15, wherein rotating thedistal anchor body comprises rotating the driver shaft.